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EC number: 927-807-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
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- Endpoint summary
- Stability
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Oral LD50 (rat) > 5000 mg/Kg bw
Inhalation LC50 (rat) > 5000 mg/m³
Dermal LD50 (rabbit) > 2000 mg/Kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989/03/01-1989/03/15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to guideline study OECD 401: GLP .
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only one dose tested
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Sex: Males (5); Females (5)
- Weight at study initiation: 102-146 g
- Housing: individual
- Diet (e.g. ad libitum): Biosure LAD 1, ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single dose of P-D 20/26 (5g/kg) was administered by oral gavage.
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- Male (5), Female (5)
- Control animals:
- no
- Details on study design:
- The acute oral toxicity of P-D 20/26 was investigated in a group of 5 male and 5 female rats. Each animal received a single oral dose of 5 g/kg administered by oral gavage. The condition of all animals was observed over a 14 day period following dosing.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed in any of the animals treated with 5 g/kg P-D 20/26.
- Clinical signs:
- other: Pilo-erection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs and recovery, as judged by external appearance and behavior, was complete by Day 2.
- Gross pathology:
- Terminal autopsy findings were normal.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for P-D 20/26 following oral gavage was >5 g/kg . Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The acute toxicity of P-D 20/26 was evaluated in rats via oral gavage at a dose of 5 g/kg bw. Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms. The animals displayed little or no abnormalities. The LD50 for P-D 20/26 following oral gavage was >5 g/kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988/5/10 - 1988/5/24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD test guideline 401. GLP.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: 9 weeks
- Weight at study initiation: males: 179-197g, females: 162-180g
- Fasting period before study: 12-18h
- Housing: individually
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, batch 95/88 rat maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water from Itingen, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: undiluted, as delivered by sponsor
- Amount of vehicle (if gavage): 5000 mg/kg
- Justification: the oral administration was used, because this is one possible route of human exposure during manufacture, handling and use of the test article - Doses:
- 5000 mg per kg bodyweight
- No. of animals per sex per dose:
- 5 males and 5 females (one dose)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations were made as to the nature, onset, severity, and duration of toxicological signs 4 times during day one, and once per day during day 2-15. Body weights were recorded on the test day prior to dosing and on Day 8 and Day 15, and at death for those which succumbed.
- Necropsy of survivors performed: yes - Statistics:
- The LOGIT-model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: 5000 mg/kg: sedation, dyspnea, hunched posture, ruffled fur All animals had recovered until day 5 of the observation
- Gross pathology:
- All animals were free of abnormalities at postmortem examination.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 for the test material is >5000 mg/kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
C9 -C11 cyclic aliphatics were administered via oral gavage to 5 male and 5 female rats at a dose of 5000 mg/kg to assess acute oral toxicity. Animals were observed daily for 15 days post dosing. At a dose of 5000 mg/kg, signs of toxicity were sedation, dyspnea, hunched posture and ruffled fur. All animals had recovered until day 5 of observation and survived to study termination. All animals were free of abnormalities at postmortem examination. All surviving animals displayed increases in body weight over their day 0 values. The acute oral LD50 for C9 -C11 cyclic aliphatics is >5000 mg/kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Two key read across studies from structural analogues available for assessment.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999/09/29-1999/10/22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles: GLP.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- An 8hr exposure for 3 consecutive days, one day post-treatment observation
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: WAG/RijCrlBR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deuschland, Sulzfeld, Germany
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 33-50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Test atmosphere was generated by pumping liquid C9-C11 cyclic aliphatic into stainless steel tubing using peristaltic pumps. The tubing was led through a water bath at 74 deg C and the resulting vapour was transported with an air stream from a compressed air source and added to the main airflow system. The test atmospheres were analysed by two total carbon analysers.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- total carbon analysers
- Duration of exposure:
- 8 h
- Concentrations:
- 0 (air), 1 g/m3 (170ppm), 2.5 g/m3 (430ppm), 5 g/m3 (860ppm)
- No. of animals per sex per dose:
- 8 animals per dose
- Control animals:
- yes
- Details on study design:
- Animals were exposed to the test atmosphere in modified H100 inhalation chambers Hazleton System Inc., USA). Each chamber was fitted with a manometer that allowed monitoring the slightly negative pressure inside. Three test groups (with one control) comprising of 8 rats each were exposed to Nappar 10 at different concentrations including: 0 (air), 1 g/m3 (170ppm), 2.5 g/m3 (430ppm), 5 g/m3 (860ppm). Animals were exposed to the test atmosphere 8hours/day for 3 consecutive days. All rats were checked for health and viability at least once daily. Body weight was recorded during randomization on days of testing.
- Statistics:
- All data were analyzed using the SAS statistical software package (v. 6.12). For each test measure, probability of p<= 0.05 were considered significant.
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 5 000 mg/m³ air (nominal)
- Exp. duration:
- 8 h
- Remarks on result:
- other: no deaths noted after 3 consecutive days of exposure
- Mortality:
- All animals survived to the end of the study.
- Clinical signs:
- other: One animal (2.5 g/m3) and three animals (5.0 g/m3) were noted with bloody exudation around the nose and mouth after the third exposure.
- Body weight:
- No significant changes were noted after exposure.
- Gross pathology:
- N/A
- Other findings:
- N/A
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
C9 -C11 cyclic aliphatics were administered via individual inhalation chambers for eight hours to eight Sprague-Dawley rats at vapor concentration of 0 (air), 1 g/m3 (170ppm), 2.5 g/m3 (430ppm), 5 g/m3 (860ppm) for three consecutive days. There was no mortality noted in any of the animals. Based on the conditions of this study, the LC50 for acute inhalation exposure to C9 -C11 cyclic aliphatics vapor is greater than the highest obtainable vapor concentration (5 g/m3). Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 403 : GLP.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 245-325 g
- Housing:individually
- Diet (e.g. ad libitum): ad libitum during non-exposure, food withheld while in chamber
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-76
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Exposure apparatus: 150 liter stainless steel inhalation chamber
- Exposure chamber volume: 150 liter
- Temperature, humidity, pressure in air chamber: 75° F, 48%, slight negative pressure to the room
TEST ATMOSPHERE
- Brief description of analytical method used: calibrated infrared monitor
- Samples taken from breathing zone: no
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- actual vapor concentration of6100 mg/m3
- No. of animals per sex per dose:
- 10 animals/dose (5 males; 5 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0, 7, and 14
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 6 100 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- None
- Clinical signs:
- other: None
- Body weight:
- Body weight appeared normal throughout experiment. One female lost 2 grams during the Day 7-14 post-exposure observation period.
- Gross pathology:
- All animals appeared normal.
- Other findings:
- N/A
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LC50 for acute inhalation exposure to MRD-94-979 vapor is greater than 6100 mg/m3. Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
MRD-94-979 was administered via individual inhalation chambers for four hours to ten Sprague-Dawley rats (5 males, 5 females) to an average actual vapor concentration of 6100 mg/m3 for four hours to assess acute inhalation toxicity. Animals were observed for fourteen days following exposure. There were no mortality or gross pathological alterations noted in any of the animals. Based on the conditions of this study, The LC50 for acute inhalation exposure to MRD-94-979 vapor is greater than 6100 mg/m3. Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 000 mg/m³ air
- Quality of whole database:
- Two key and two weight of evidence read across studies from structural analogues available for assessment.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1992/11/10-1992/11/24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles: GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- ; 1987 Guidelines
- Deviations:
- yes
- Remarks:
- occlusive dressing used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products
-Sex: Male (3); Female (3)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: Male: 2.01 to 2.21 kg; Female: 2.17 to 2.48 kg
- Housing: individually housed
- Diet (e.g. ad libitum): AgwayCertified Diet RCA Rabbit, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8-day acclimatization
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-70
- Humidity (%): 40 to 60
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day prior to application the trunk of each animal was clipped free of hair. For each treated animal, 5000 mg/kg of MRD-92-405 was applied to the trunk beneath a gauze patch and secured by an occlusive wrap to prevent evaporation. The whole patch assembly was held in place with tape. The patches were left in position for approximately 24 hours. Residual test material was removed and animals were observed 1, 2.5, and 4 hours after dosing and once per day thereafter for a total of 14 days.
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg: (3) males; (3) female
- No. of animals per sex per dose:
- Animals: (3) males; (3) female
- Control animals:
- no
- Details on study design:
- SCORING SYSTEM: Draize scale
- Dermal response observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Differences between treated and control group mean values for bodyweight gain were analysed by Student's t-test. Where individual variance ratios were significant (P <0.05 or less), Cochrans approximation was applied (Snedecor and Cochran, Statistical Methods, 6th Ed. Iowa State. 1973). Where zero variance was found in one or more groups, intergroup comparison was performed by the Wilcoxon Rank Sum Test.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no animal deaths prior to study termination.
- Clinical signs:
- other: Well-defined erythema was noted upon removal of the test patches in all animals exposed to MRD-92-405, with edema noted in two animals. At Day 14, three animals were noted as having very slight erythema and only one animal was noted as having well-defined
- Gross pathology:
- One animal was free of macroscopic abnormalities. Five animals were observed with desquamation.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of MRD-92-405 was > 5000 mg/kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Three male and three female rabbits were exposed to MRD-92-405 for 24h via an occluded patch. Dermal evaluations occurred at 24 hours post patch removal and once daily until the study termination at day 14. Exposure had no affect on viability; all animals survived the exposure. The LD50 of MRD-92-405 was > 5000 mg/kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989/01/27 - 1989/02/10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to guideline study OECD 402: GLP .
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
-Sex: Male (5); Female (5)
- Weight at study initiation: 209 to 254 g
- Housing: individually housed
- Diet (e.g. ad libitum): Labsure LAD 1, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 71%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day prior to application the trunk of each animal was clipped free of hair. For each treated animal, 2000 mg/kg of P-D 20/26 was applied to the trunk beneath a gauze patch and secured by an occlusive wrap to prevent evaporation. The whole patch assembly was held in place with tape. The patches were left in position for approximately 24 hours. Residual test material was removed and animals were observed soon after dosing and twice per day thereafter for a total of 14 days.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg: (5) males; (5) female
- No. of animals per sex per dose:
- Animals: (5) males; (5) female
- Control animals:
- no
- Details on study design:
- SCORING SYSTEM: Draize scale
- Dermal response observations: daily
- Other examinations performed: clinical signs, body weight - Statistics:
- Differences between treated and control group mean values for bodyweight gain were analysed by Student's t-test. Where individual variance ratios were significant (P <0.05 or less), Cochran's approximation was applied (Snedecor and Cochran, Statistical Methods, 6th Ed. Iowa State. 1973). Where zero variance was found in one or more groups, intergroup comparison was performed by the Wilcoxon Rank Sum Test.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no animal deaths prior to study termination.
- Clinical signs:
- other: Well-defined erythema accompanied by slight oedema was observed in all five males and one female after removal of the dressings. A small amount of test substance remained on the skin site in these animals. Slight erythema only was observed in the remainin
- Gross pathology:
- Terminal autopsy findings were normal.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of P-D 20/26 was > 2000 mg/kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Five male and five female rabbits were exposed to P-D 20/26 for 24h via an occluded patch. Dermal evaluations occurred at 24 hours post patch removal and twice daily until the study termination at day 14. Exposure had no affect on viability; all animals survived the exposure. The LD50 of P-D 20/26 was > 2000 mg/kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline : GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton
- Age at study initiation: 19 weeks
- Weight at study initiation: 3.14-3.51
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 50 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-71
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shoulder region to lumbar region
- Type of wrap if used: gauze and plastic sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing, wiped with gauze
- Time after start of exposure: 24h - Duration of exposure:
- The test material was applied to the skin at the appropriate dose, covered with a gauze patch, secured with tape, and covered with a plastic sleeve. After ca. 24h of exposure, the plastic sleeve, tape and gauze patch were removed. The skin was then wiped (but not washed) with gauze and water to remove any remaining test material.
- Doses:
- The test material was applied to the skin at the appropriate dose, covered with a gauze patch, secured with tape, and covered with a plastic sleeve. After ca. 24h of exposure, the plastic sleeve, tape and gauze patch were removed. The skin was then wiped (but not washed) with gauze and water to remove any remaining test material.
- No. of animals per sex per dose:
- 6 animals/dose (3 males; 3 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:2, 4, 24 hours after dosing and daily for 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- The means and standard deviations of the body weights were calculated.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 3 160 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: There was an overall low incidence of clinical in-life observations noted during the study. Observations included nasal discharge, dry rales, alopecia. Topical exposure elicited very slight to well defined erythema in all animals and very slight edema i
- Gross pathology:
- N/A
- Other findings:
- N/A
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 for MRD-83-349 is greater than 3160 mg/kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The acute dermal toxicity of MRD-83-349 was evaluated in rabbits following topical occlusive exposure. Test material was applied as a single dose of 3160 mg/kg to the clipped backs of 3 male and 3 female rabbits, covered with a gauze patch, and secured with non-irritating tape and a plastic sleeve. The test material remained in contact with the skin for 24 hours. Observations were made as to the nature, onset, severity, and duration of toxicological signs 2, 4, and 24 hours after dosing and once per day thereafter, for a total of 14 days. Dermal responses were evaluated 24 hours after topical application and on Days 3, 7, 10, and 14 according to the Draize method of scoring. Application of MRD-83-349 at a dose level of 3160 mg/kg showed no evidence of systemic toxicity under the conditions of this study and all animals survived to study termination. There were no deaths or treatment-related clinical signs. Topical exposure elicited very slight to well defined erythema in all animals and very slight edema in four animals. Desquamation was noted in five animals during the study. By Day 14, all animals were clear of erythema and edema. Based on the results of this study, the dermal LD50 for MRD-83-349 is greater than 3160 mg/kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Three key read across studies from structural analogues available for assessment.
Additional information
There is no data available for Hydrocarbons, C9-C11, n-alkanes, >2% aromatics. However, data is available for structural analogues, Nonane; Hydrocarbons, C9-C11, cyclics, < 2% aromatics; Hydrocarbons, C9-C11, isoalkanes, < 2% aromatics; Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics; Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics; and Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics and presented in the dossier. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
Acute Oral Toxicity
Hydrocarbons, C9-C11, cyclics, < 2% aromatics
C9-C11 cyclic aliphatics were administered via oral gavage to 5 male and 5 female rats at a dose of 5000 mg/Kg to assess acute oral toxicity (ExxonMobil, 1988). Animals were observed daily for 15 days post dosing. At a dose of 5000 mg/Kg, signs of toxicity were sedation, dyspnea, hunched posture and ruffled fur. All animals had recovered until day 5 of observation and survived to study termination. All animals were free of abnormalities at post-mortem examination. All surviving animals displayed increases in body weight over their day 0 values. The acute oral LD50for C9-C11 cyclic aliphatics is >5000 mg/Kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics
The acute toxicity of Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics was evaluated in rats via oral gavage at a dose of 5 g/Kg bw (ExxonMobil, 1989). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms. The animals displayed little or no abnormalities. The LD50for Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics following oral gavage was >5 g/Kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Acute lnhalation Toxicity
Nonane
In a study (Nilsen et al., 1988), ten male Sprague-Dawley rats per concentration were exposed to nonane via inhalation at 2414, 3560, 4438, or 5280 ppm for 8 hours.During inhalation all animals were observed at 15 and 30 min. intervals. For the first 8 hours after exposure all animals were observed at hourly, then at 2 hours intervals during daytime for 14 consecutive days. All animals were subjected to complete necropsy which included examination of the external surface of the body, all orifices, and the cranial, thoracic and abdominal cavities and their contents. In addition to general activity, acute effects as coordination difficulties, tremor, spasms and lethality were monitored. The LC50was determined to be ca. 23.76 mg/L and therefore, under the conditions of this study, the test substance is not classified.
In a second study (Carpenter et al., 1978), sixteen male rats were exposed to a single 4 hr concentration of n-nonane. Ten rats were pre-selected for the LC50determination; six rats were sacrificed for histological examination, 3 immediately after exposure, 3 after 2 more days post exposure. LC50rats were observed continuously for the first 5 min of exposure, then at 15 and 30 min, and at 30 min intervals until 1 hr post-exposure, and daily thereafter for 14 days. Gross necropsy was performed on all animals at death or sacrifice. Histopathologic evaluation was made of the respiratory tract and liver from 3 rats/group killed at the completion of exposure and 2 days postexposure. Histopathologic evaluation of the respiratory tract, liver, kidney, brain and bone marrow was made on 3 rats/group sacrificed after the 14 day observation period. Micropathological evaluation of tissues taken at necropsy, 14 days following the single 4-hr inhalation periods, revealed no lesion attributable to vapour inhalation. The LC50was determined to be 17 mg/L in male rats.
Hydrocarbons, C9-C11, isoalkanes, <2% aromatics
In a key study (ExxonMobil, 2001), the test material (Hydrocarbons, C9-C11, isoalkanes, <2% aromatics) was administered via individual inhalation chambers for eight hours to eight Sprague-Dawley rats at vapor concentration of 0 (air), 1 g/m3(170 ppm), 2.5 g/m3(430 ppm), 5 g/m3(860 ppm) for three consecutive days. There was no mortality noted in any of the animals. Based on the conditions of this study, the LC50for acute inhalation exposure to Hydrocarbons, C9-C11, isoalkanes, <2% aromatics vapor is greater than the highest obtainable vapor concentration (5 g/m3). Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics
Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics was administered via individual inhalation chambers for four hours to ten Sprague-Dawley rats (5 males, 5 females) to an average actual vapor concentration of 6100 mg/m3for four hours to assess acute inhalation toxicity (ExxonMobil, 1995). Animals were observed for fourteen days following exposure. There were no mortality or gross pathological alterations noted in any of the animals. Based on the conditions of this study, the LC50for acute inhalation exposure to Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics vapor is greater than 6100 mg/m3. Classification as an acute inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Acute Dermal Toxicity
Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics
The acute dermal toxicity of Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics was evaluated in rabbits following topical occlusive exposure (ExxonMoil, 1984). The test material was applied as a single dose of 3160 mg/Kg to the clipped backs of 3 male and 3 female rabbits, covered with a gauze patch, and secured with non-irritating tape and a plastic sleeve. The test material remained in contact with the skin for 24 hours. Observations were made as to the nature, onset, severity, and duration of toxicological signs 2, 4, and 24 hours after dosing and once per day thereafter, for a total of 14 days. Dermal responses were evaluated 24 hours after topical application and on Days 3, 7, 10, and 14 according to the Draize method of scoring. Application of Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics at a dose level of 3160 mg/Kg showed no evidence of systemic toxicity under the conditions of this study and all animals survived to study termination. There were no deaths or treatment-related clinical signs. Topical exposure elicited very slight to well defined erythema in all animals and very slight edema in four animals. Desquamation was noted in five animals during the study. By Day 14, all animals were clear of erythema and edema. Based on the results of this study, the dermal LD50for Hydrocarbons, C9-C11, isoalkanes, cyclics, < 2% aromatics is greater than 3160 mg/Kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics
Three male and three female rabbits were exposed to Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics for 24h via an occluded patch (ExxonMobil, 1993). Dermal evaluations occurred at 24 hours post patch removal and once daily until the study termination at day 14. Exposure had no effect on viability; all animals survived the exposure. The LD50of Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics was > 5000 mg/Kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics
Five male and five female rabbits were exposed to Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics for 24h via an occluded patch (Cepsa Quimica, 1989). Dermal evaluations occurred at 24 hours post patch removal and twice daily until the study termination at day 14. Exposure had no effect on viability; all animals survived the exposure. The LD50of Hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics was > 2000 mg/Kg. Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Justification for classification or non-classification
Based on available read across data, Hydrocarbons, C9-C11, n-alkanes, <2% aromatics is minimally toxic via ingestion where the LD50 is >5000 mg/Kg, via dermal exposure where the LD50 is >2000 mg/Kg, and by inhalation where the LC50 >5000 mg/m3. These findings do not warrant classification under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C9-C11, n-alkanes, <2% aromatics is classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm2/s).
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